C1 Esterase Inhibitor (Recombinant) (Ruconest)
C1 Esterase Inhibitor (Recombinant) is an FDA-licensed reference biologic from Pharming Americas BV. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2014
Reference approved
Reference product
Ruconest C1 Esterase Inhibitor (Recombinant)
Pharming Americas BV
- Approved
- Jul 16, 2014
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for C1 Esterase Inhibitor (Recombinant), in chronological order.
First licensure
Date C1 Esterase Inhibitor (Recombinant) was first licensed by the FDA.
12 yr 1 mo ago
Reference approval
Approval date of the reference C1 Esterase Inhibitor (Recombinant) product.
12 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
4 yr 11 mo ago
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 2 mo
Frequently asked questions
Are there biosimilars approved for C1 Esterase Inhibitor (Recombinant) (Ruconest)?
No 351(k) biosimilars or interchangeable biosimilars referencing C1 Esterase Inhibitor (Recombinant) are listed in the FDA Purple Book yet.
When does C1 Esterase Inhibitor (Recombinant) (Ruconest) lose reference-product exclusivity?
C1 Esterase Inhibitor (Recombinant)'s 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending July 16, 2026.
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